Elevar Therapeutics, a US subsidiary of South Korea’s HLB LifeScience, and China’s Jiangsu Hengrui Pharmaceuticals on 21 March received a complete response letter from the US Food and Drug Administration on the pair’s resubmitted new drug application for a combination therapy for a form of liver cancer with a higher prevalence in Asian populations.
Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
